Gexfix International Corp.
Country not established
- Devices
- 1
What Gexfix International Corp. makes
Gexfix International Corp. manufactures external fixation devices, used primarily for stabilizing and supporting fractured bones in orthopedic applications. These systems are designed to maintain proper alignment during the healing process, often employed in trauma and reconstructive surgeries.
The company’s external fixation devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The portfolio is listed in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
Gexfix External Fixation Ref K160972
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gexfix International Corp. have in the registry?
The registry currently lists 1 device for Gexfix International Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gexfix International Corp.'s devices?
Among its 1 most recently registered device, Gexfix International Corp. has devices listed in FDA 510(k) (1 device).
What risk classes do Gexfix International Corp.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Gexfix International Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gexfix International Corp. in the registry?
The most recently registered devices listed for Gexfix International Corp. include Gexfix External Fixation.